Partnering For Scalable Suspension Processes Tailored To AAV Gene Therapies

By Samir Acharya, Andelyn Biosciences

Achieving optimized, scalable suspension processes for adeno-associated virus (AAV)-based therapeutics comes with a number of technical and business challenges. Many biotherapeutic companies experience hurdles while transitioning from adherent platforms to suspension, as well as when scaling suspension processes to meet the needs of commercial scale. These realities make it critical to identify the right manufacturing partner that can overcome these hurdles. The ideal partner will have the know-how and experience to optimize unit operations, the expertise to maximize yields without compromising quality, and capabilities that enable phase-appropriate production that is adaptable to changing client needs.

Andelyn Biosciences is a gene therapy contract development and manufacturing organization (CDMO) originally spun out of Nationwide Children’s Hospital (NCH) with all of these attributes. Andelyn possesses deep expertise supporting AAV therapies from preclinical to commercial production for both adherent and suspension processes. While having been at the forefront of AAV development and production using an adherent platform for over two decades, Andelyn has also leveraged its know-how for its AAV suspension platform to achieve the highest, most consistent quality and yields possible, from 125 milliliter flasks to 2,000-liter bioreactors and every scale in between.